The Recall Desk

FDA (Devices) recall action 65779

Becton Dickinson & Co. recalled 3 products on 2013-09-04

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2013-09-04
Critical
0
Units
2,670

Why these products were recalled

PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2013-09-04

    Becton Dickinson PrepStain Tecan US-II Recall for Incorrect Rack Setting

    Becton Dickinson is recalling 890 PrepStain Tecan US-II instruments because a rack setting was incorrectly entered during routine maintenance.

    Product
    PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2013-09-04

    Becton Dickinson PrepStain Tecan US-I Recall for Incorrect Rack Settings

    Becton Dickinson is recalling 890 PrepStain Tecan US-I instruments because a rack setting was incorrectly entered during routine maintenance.

    Product
    PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
    Category
    Distribution
    1 state